The Miami, Orlando, Tampa, Fort Lauderdale, Jacksonville, Florida mesh lawsuits are being filed for a vaginal mesh or bladder sling OB tape, TVT mesh, pelvic mesh, or surgical mesh. These are all part of the Miami, Orlando, Tampa, Fort Lauderdale, Jacksonville, mesh lawsuits and our experienced Florida Pelvic mesh attorneys are familiar with filing a lawsuit for all of these.

]]>FDA’s Proposed Tracking System Could Reduce Vaginal Mesh Complicationshttp://vaginalmeshhelpline.com/fdas-proposed-tracking-system-could-reduce-vaginal-mesh-complications Thu, 09 Aug 2012 18:43:27 +0000http://vaginalmeshhelpline.com/?p=1745The Vaginal Mesh Helpline continues to report on the news that effects women with vaginal mesh complications. The new FDA tracking system comes a little late for the over 300,000 women implanted with vaginal mesh devices and suffering. However, there is hope. This sends a message that our voices have been heard. By filing vaginal […]

]]>The Vaginal Mesh Helpline continues to report on the news that effects women with vaginal mesh complications. The new FDA tracking system comes a little late for the over 300,000 women implanted with vaginal mesh devices and suffering. However, there is hope. This sends a message that our voices have been heard. By filing vaginal mesh lawsuits and standing up for justice you protect yourself and all women from becoming targets of manufacturers who put profits over people.

The FDA has proposed a new regulation that would require all new medical devices to carry a unique device identifier (UDI). The UDI would be a code of letters and numbers. Such a code would make it much easier to track devices, which in turn would make it much easier to report complications with a particular model or to find out about such problems.

According to the FDA, “A UDI system has the potential to improve the quality of information in medical device adverse event reports, which will help the FDA identify product problems more quickly, better target recalls and improve patient safety.”

For example, if such a tracking system were in place, a doctor who had a patient with stress urinary incontinence (SUI) or pelvic organ prolapse (POP) and wanted to implant a vaginal mesh device could look up the different models by the UDI and immediately see what transvaginal mesh complications, if any, had been reported with each specific model. Likewise, in the event of a recall, a UDI would make the process much more efficient: the company or the FDA would simply announce that the model carrying a particular UDI number was being recalled.

The FDA’s proposal was a response to legislation passed by Congress in 2007 that directed the FDA to develop regulations establishing a unique device identification system for medical devices. Many women have suffered transvaginal mesh complications

Such a system might enable future patients to avoid problems resulting from transvaginal mesh. Many women have suffered such complications, including pain, infections, mesh erosion, protrusion, vaginal scarring, dyspareunia, and perforation of the bowels, bladder, or blood vessels. Many of these devices were approved under the FDA’s controversial 510(k) approval process, which allows products to be approved without first undergoing clinical trials to prove they are safe.

If the physicians treating these women had been able to easily look up the type of vaginal mesh device they were considering implanting, and immediately see reports of problems associated with the device, they would have been able to weight the risks and make an informed decision about whether to implant that particular device. Vaginal mesh MDL consolidated lawsuits

Many women who have suffered complications have filed vaginal mesh lawsuits in order to get compensation for their pain, suffering, and reduced quality of life. Most of these lawsuits charge that the manufacturers of these devices did not test them for safety before putting the on the market and failed to warn the public of the devices’ risks. A number of federal lawsuits have been consolidated in a vaginal mesh MDL in West Virginia.

For help call the Vaginal Mesh Helpline and Vaginal Mesh Support Group today, Let us help you find and vaginal mesh lawyer and doctor.

]]>Vaginal Mesh Overview, Vaginal Mesh Lawyershttp://vaginalmeshhelpline.com/vaginal-mesh-overview-vaginal-mesh-lawyers Wed, 08 Aug 2012 03:10:54 +0000http://vaginalmeshhelpline.com/?p=1734The Mesh Helpline still hears from women who are having complications and just realized it is from the mesh. Most of these women have seen a lawyer ad on T.V which alerts them to realize they are not alone and that their doctors are giving them the run around. Other women are disenchanted with the […]

]]>The Mesh Helpline still hears from women who are having complications and just realized it is from the mesh. Most of these women have seen a lawyer ad on T.V which alerts them to realize they are not alone and that their doctors are giving them the run around. Other women are disenchanted with the T.V ad lawyer they hired or a local lawyer who has sent the case to another lawyer someplace else. There are some basic vaginal mesh guidelines:

Vaginal mesh complications include pain, leakage or incontinence or the bladder or bowel, parch bleeding, infection, pain during sexual intercourse, lower back pain, pain on one side of the body, abdominal pain and difficulty standing for long periods

You are not alone. Close to 400,000 women have vaginal mesh or bladder sling implants

A vaginal mesh comes in many varieties, made by many different manufufacturers. They can be called a sling, a transvaginal mesh, a TVT sling, a bladder sling, a surgical mesh, a vaginal patch and it is still a mesh and part of the Vaginal mesh lawsuts currently underway.

For the men: Sexual intercourse is indeed painful for your wife. She is not lying or making it up. But, with the right doctor there is hope of resuming a normal life. Many men are sueing with their spouse. A California husband just got an award for $500,000 for loss of intimacy in the relationship.

The mesh can be removed and your body repaired with sutures or another means. A urogynecologist is usually a mesh specialist although a GYN surgeon or urologist can remove the mesh. You must ask the doctors office if the doctor has ever removed a mesh and you must get a straight answer.

Physical therapy will not help the mesh and may be dangerous by pushing it into an organ. This is not a good idea. Estrogen creme will not necessarily help either. You must look into mesh removal.

The vaginal mesh lawsuits are currently underway. It is important to retain a lawyer, and the right lawyer, asap. Statutes of limitations are running out in some states. You will have to go to a doctor to get a statement that you have a mesh problem. If you rely on old medical records it may become harder to prove your case. The best situation is to have a statement in the record that mesh removal or alteration is needed and that you have a mesh issue.

Additional Important Information

Surgical mesh was designed in the 1950s to correct abdominal hernias. The woven material is placed below the skin to patch the abdominal hole and block intestines and other tissues from protruding through the abdominal wall.

Surgical mesh can be made of biological materials or synthetic materials like polypropylene, polytetrafluoroethylene, polyester fibers or stainless steel. The size, shape, thickness and flexibility vary based on the surgeon’s needs. Often, the mesh comes in a prepackaged kit with the necessary tools, to make the procedure easier.

The Food and Drug Administration (FDA) reports that hundreds of thousands of hernia repair surgeries are performed each year — with and without surgical mesh — and patients typically recover quickly. However, the FDA has received reports of adverse reactions to the mesh, adhesions (where the loops of the intestines attach to each other or the mesh), and injury to organs, nerves or blood vessels.

Overall, the treatment of hernias with surgical mesh is considered successful, so doctors wanted to use it in other parts of the body that required additional support. In the 1970s, they began inserting surgical mesh abdominally to treat pelvic organ prolapse (POP). In 1996, the FDA approved the first mesh product for treatment of stress urinary incontinence (SUI). The first mesh product for treatment of prolapse was approved in 2002.

Instead of inserting the mesh through abdominal incisions, however, surgeons have recently embraced the idea of implanting the mesh transvaginally (through the vagina). This choice has been disastrous for thousands of women, who have suffered severe complications such as organ perforation and erosion of the mesh. Even revision surgeries cannot always remove the mesh or correct the internal trauma. Transvaginal Mesh and Pelvic Organ Prolapse

To treat pelvic organ prolapse, surgical mesh can be implanted at the time of a hysterectomy or as a separate surgery. When surgical mesh is inserted through the vagina, it is referred to as transvaginal mesh.

Pelvic organ prolapse is a condition in which the bladder, top of the vagina, uterus, rectum or bowel has descended from its normal position. The condition is thought to be the result of weakened pelvic muscles, usually from pregnancy and childbirth. Of the 300,000 surgical procedures done to correct prolapse in 2010, 100,000 used mesh and 75,000 of those were completed transvaginally.

When transvaginal mesh is used to repair prolapse, the surgeon uses the woven material to create a hammock-like structure under the drooping organ or organs. Once in place, the mesh is anchored to muscles or ligaments by sutures or other devices. Over time, the patient’s tissues grow and fill in the pores of the mesh to keep it stable. The hammock, in turn, maintains the correct position of the affected organ. To treat prolapse, transvaginal mesh is most commonly placed in these locations:

The anterior vaginal wall to correct a bladder prolapse. The posterior vaginal wall to correct a rectal prolapse. The top of the vagina to correct a uterine prolapse.

The most common and serious of the complications for patients is the erosion, or extrusion, of the mesh into nearby organs. This can lead to bleeding, pain during sexual intercourse and urinary problems. Revision surgeries may not fix the problem. And if the patient’s tissues have already grown through the mesh, removal may be impossible. Transvaginal Mesh and Stress Urinary Incontinence

Surgical mesh can also be used to create a bladder sling that is positioned under the urethra and bladder neck and anchored on the sides. The bladder sling is designed to treat stress urinary incontinence (SUI), which occurs when the bladder is stressed by an everyday activity, such as sneezing or laughing, and subsequently leaks urine. The sling keeps the urethra and bladder neck closed during normal activities, stopping the leakage. In 2010, nearly 260,000 surgeries were performed to correct SUI. Of those, 80 percent were performed using surgical mesh implanted transvaginally.

When a bladder sling is inserted through the vagina, it is known as transvaginal mesh. Typically, small abdominal incisions are also used. Among the most popular bladder slings:

Tension-free vaginal tape (TVT): A polypropylene mesh tape is used under the urethra and is held in place by the patient’s body. Transobturator tape (TOT): Less invasive than TVT, because there is no need to use a large needle when inserting it. Mini-sling: Eliminates the need for abdominal incisions. A metallic inserter and a vaginal incision are used to place the mesh tape.

As with prolapse surgery, there have been widespread reports of serious complications after bladder sling surgery using transvaginal mesh. Many patients have prolonged difficulty urinating or they incur new symptoms of incontinence, specifically urgency. In addition, they run the risk of the slings eroding into nearby structures, organ perforation, infection at the surgery site and internal bleeding. Transvaginal Mesh and the FDA

Between 2005 and 2007, the FDA received 1,000 reports of complications and injuries related to transvaginal mesh surgeries, including death. The FDA decided to begin studying the medical device in October 2008. The FDA reported that between 2008 and 2010, there were nearly 2,900 reports of injuries caused by transvaginal mesh.

By July 2011, the federal agency concluded in a public safety update that complications with the use of transvaginal mesh for treatment of prolapse are not rare and that mesh repairs are no more effective than non-mesh repairs for treating prolapse.

The FDA took its concern a step further in January 2012, stating that after studying years of scientific data and recommendations from the September 2011 Obstetrics-Gynecology Devices Panel meeting, it was considering reclassifying transvaginal mesh as a high-risk device. If that happens, mesh devices will be subjected to more rigorous testing, including clinical trials with humans.

In that same update, the FDA requested safety data from all surgical mesh manufacturers and ordered post-market studies from seven manufacturers of single-incision mini-slings for SUI and 33 manufacturers of surgical mesh for prolapse.

If you need help with your vaginal mesh call the Vaginal Mesh Helpline today.

]]>Couple Wins Big on Vaginal Mesh Lawsuit, Millions in Vaginal Mesh Settlementhttp://vaginalmeshhelpline.com/couple-wins-big-on-vaginal-mesh-lawsuit-millions-in-vaginal-mesh-settlement Tue, 24 Jul 2012 13:58:01 +0000http://vaginalmeshhelpline.com/?p=1724The Vaginal Mesh Helpline is seeking all women with a vaginal mesh to help you file your vaginal mesh lawsuit. Ladies, please do not wait. Time is running out. This couple won and won big. Justice spoke and responded to their suffering. Many women we speak to are waiting. Do not wait. Some of the […]

]]>The Vaginal Mesh Helpline is seeking all women with a vaginal mesh to help you file your vaginal mesh lawsuit. Ladies, please do not wait. Time is running out. This couple won and won big. Justice spoke and responded to their suffering. Many women we speak to are waiting. Do not wait. Some of the state statutes are running close. See the settlement for this couple below.

Couple wins landmark trial against Vaginal Mesh medical company. File Your vaginal Mesh lawsuit today. Call the vaginal mesh helpline and get a vaginal mesh lawyer that will work with your best interests at heart. This couple won big and they did not get their case referred around the country from lawyer to lawyer. You must get a vaginal mesh lawyer who is keeping your case or works with a known lead lawyer. KNow where your case is. Get the vaginal mesh settlement you deserve.

Legal and medical professionals from across the country are paying very close attention to a groundbreaking verdict that happened in Bakersfield. For the first time in the nation, a jury has awarded a local couple $5.5 million against the maker of a medical implant, claiming they knew their product was unsafe. Christine Scott got the official news Monday morning at Kern County Superior Courthouse. She had a vaginal mesh surgically implanted and has had complications ever since. She and her husband sued the maker and won, making it the first victory of its kind in the nation. “I was like ‘Thank you, God.’ We can finally get the word out to women,” said Scott after the verdict. After some four years of legal battles and court-ordered silence with the maker of the Avaulta Mesh, C.R. Bard Medical, Scott gets some relief from the victory. An active runner, Scott got the implant to correct a leaky bladder. But, the device began cutting her colon, and tissue continues to grow through the tiny holes in the mesh. She had already had eight surgeries when we first met Scott last month. “I don’t know if I’ll have ten surgeries now. I don’t know if I’ll have one. I don’t know if I’ll have 100. The doctors cannot tell me,” Scott said in June. A jury awarded Scott $5 million and her husband $500,000, claiming the mesh has ruined their love life. It’s a landmark victory, the first of its kind in the country. The Securities and Exchange Commission indicates 47,000 women have had the mesh implanted, and 650 lawsuits are pending. “In fact, this case, they advertised it as FDA-approved. It’s not. It’s a crime,” said Gene Lorenz, a lawyer representing Scott. The lawyer for C.R. Bard Medical says the company stopped selling the Avaulta Mesh on July 1, 2012 in the United States because the FDA wanted more clinical trials done. But, it’s still sold in other countries. “This is a product that has been cleared for use by the FDA and can be safe and effective when used properly and for the right patient,” said Michael Brown, attorney for C.R. Bard Medical. “They tested this on 16 rats, 12 rabbits, four sheep and, by their own researcher’s admission, the next living being this product went into was women,” said Elaine Houghton, Scott’s attorney. Scott says she will continue to deal with complications from the mesh, while being a voice for other women. “The hardest part, I will tell you, through this whole thing, is having to keep quiet, watching women still get hurt. But, I was legally not able to get out there and tell and that, I’m sorry,” said Scott holding back tears. “And, that every day I was like please be over so I can talk. So, when I got that verdict it was like ‘Thank you God.’ Now we can do something.” There will likely be an appeal in the case, but Scott says she’s just happy to no longer have the court-ordered silence, so she can talk about it. She wants to start a support group for women. And, her lawyers are working on a website for people wanting to know more about mesh implants. They hope to have that up and running by Monday.

Call us today and let us help you find a vaginal mesh lawyer and doctor. With so many lawyers advertising and so few doctors willing to help it is very difficult to know what to do. Call and speak to our female medical social worker today.

]]>Vaginal Mesh Helpline is provideng vaginal mesh support and Avaulta mesh lawyers for women with complications from the Bard Avaulta Vaginall Mesh. Like all mesh implants the Bard Avaulta Vaginal Mesh was used for prolapse or unrinary incontinence and is causing all the classic mesh complications.

If you have complications from a Bard Avaulta vaginal mesh do not wait because the first Bellwether trial is scheduled in the Bard Avaulta Mesh Implant MDL

The trial is now set to begin on February 5, 2013 in the U.S. District Court for the Southern District of West Virginia.

The purpose of bellwether trials is for both parties to get an idea of how juries will respond to common evidence in representative trials. They can then use this information to negotiate settlements, to plan their strategy for future trials, or to serve as precedents. In January, Judge Goodwin told the attorneys in the Bard MDL to compile a list of possible bellwether cases. Now that a date has been set for the first bellwether trial, a schedule will be established for the discovery process so that the pre-trial proceedings can begin.

]]>http://vaginalmeshhelpline.com/avaulta-vaginal-mesh-helpline-bard-avaulta-vaginal-mesh-lawyer/feed1Vaginal Mesh Lawsuits, Vaginal Mesh Multi District Litigations Proceedingshttp://vaginalmeshhelpline.com/vaginal-mesh-lawsuits-vaginal-mesh-multi-district-litigations-proceedings Mon, 09 Jul 2012 01:13:07 +0000http://vaginalmeshhelpline.com/?p=1678You have been probably reading alot lately about the mesh and the fact that it is a Multi District litigation. In fact that is what this lawsuit is. The vaginal mesh is not a class action lawsuit. Your case is filed locally and then moved to the appropriate MDl that the manufacturer of your vaginal […]

]]>You have been probably reading alot lately about the mesh and the fact that it is a Multi District litigation. In fact that is what this lawsuit is. The vaginal mesh is not a class action lawsuit. Your case is filed locally and then moved to the appropriate MDl that the manufacturer of your vaginal mesh has been assigned to.

What is a MUlti District litigation ?

Multidistrict litigation is a procedure utilized in the federal court system to transfer to one federal judge all pending civil cases of a similar type filed throughout the United States. The decision whether cases should be transferred is made by a panel of seven federal judges appointed by the Chief Justice of the United States Supreme Court. The Judicial Panel on Multidistrict Litigation meets periodically to review requests that cases be consolidated for pretrial matters pursuant to 28 U.S.C. § 1407

Vaginal mesh MDL’S

In December 2008, all Mentor ObTape lawsuits pending in federal courts were consolidated for MDL in the United States District Court for the Middle District of Georgia, before the Honorable Judge Clay D. Land. In October 2010, 36 lawsuits against Bard (manufacturer of one brand of vaginal mesh) were consolidated for MDL in the Southern District of West Virginia; the number of included cases has since grown to nearly 300. The first vaginal mesh bellwether trial against Bard is scheduled to begin on February 15, 2013. Later, in February 2012, the Judicial Panel on Multidistrict Litigation created three additional MDLs in the Southern District of West Virginia; the defendants are: American Medical Systems; Boston Scientific; and Ethicon. Also in October 2010, Judge Carol E. Higbee of the Superior Court of New Jersey ruled in favor of centralized management for all current and future complaints against manufacturers Johnson &Johnson and Bard (more than 400 such cases have currently been filed). The New Jersey cases are not part of a federal MDL, but are being managed on a state level.

A motion has been filed to create a sixth transvaginal mesh MDL, involving lawsuits over Coloplast pelvic mesh, and a panel of federal judges will meet later this month to consider whether the cases should be consolidated for pretrial proceedings and centralized before the same judge in West Virginia who is presiding over cases involving similar products sold by other manufacturers.

To Summarizethe vaginal mesh MDL

There are currently four different MDLs (multidistrict litigations) centralized before Chief District Judge Joseph R. Goodwin in the U.S. District Court for the Southern District of West Virginia, involving lawsuits over transvaginal mesh products sold by C.R. Bard, American Medical Systems (AMS), Boston Scientific and Ethicon.

A fifth MDL, which was established in 2004 for lawsuits involving Mentor ObTape, is centralized in the U.S. District Court for the Middle District of Georgia. However, many of the Mentor ObTape lawsuits have already settled and the litigation is at a very advanced stage.

On June 14, 2012, Chief District Judge Joseph R. Goodwin, who presides over the U.S. District Court for the Western District of West Virginia, issued a pretrial order to proceed with discovery processes in the transvaginal mesh lawsuit MDL. In laymen’s terms, this means that lawyers for the plaintiffs, who allege a variety of vaginal mesh problems, are now able to request evidence, documentation and other paperwork from product manufactures and defendant companies.Discovery to seek evidence of vaginal mesh problems

True to name, discovery is a legal term for the pretrial process of “discovering” evidence from the opposing party. In this case, Judge Goodwin has authorized vaginal mesh attorneys to seek depositions, interrogatories (fact-gathering questionnaires), and other supporting documentation from vaginal mesh manufacturers and other named defendants. Judge Goodwin’s order is a very important step for the MDL, as it allows counsel to prepare for the first trials.Judge presides over four transvaginal mesh lawsuit MDL’s

Judge Goodwin will preside over several transvaginal mesh lawsuit MDL’s – those against American Medical Systems, Boston Scientific, C.R. Bard, and Ethicon. While Judge Goodwin has been assigned to the C.R. Bard MDL since 2010, it was not until 2012 that the other three were consolidated and appended to his court docket. The four MDL’s consolidate cases from thousands of women, and currently number 333 against AMS, 182 against Boston Scientific, 411 against C.R. Bard, and 253 against Ethicon. MDL numbers are growing fast, and this rapid rate is not expected to decrease in the near future.Vaginal mesh attorneys cite range of complications

MDL plaintiffs allege several vaginal mesh problems, among them pelvic organ prolapse and stress urinary incontinence aggravated by vaginal mesh. Additionally, women report chronic infection, bleeding, vaginal scarring, severe discomfort, and pain during intercourse. For some, what was meant to be a solution to their problems results in device erosion – deterioration of the implant – or extrusion, in other words, dislocation of the implant to such a point that it protrudes into the vaginal canal. In the worst of cases, women allege that their defective implants cannot be completely removed, even after multiple surgeries.

It is important to understand that a local lawyer is not necessary for the Vaginal mesh lawsuits. That lawyer will not necessarily be a part of the proceedings but, will most likely be seniding your case to another law firm that is equipped to handle mass torts.

Lead Counsels and the vaginal mesh MDL

On April 13th, Chief Judge Joseph R. Goodwin held a hearing to consider what MDL attorneys will be appointed to serve as lead counsel for the plaintiffs in the consolidated transvaginal mesh litigation. Attiorneys from around the country comprise the Executive Committee and fifty firms comprise the PSC.

That is why it is extremely important for you to hire an end of the line lawyer so that your casr is not moved from a local law firm to a larger law firm to the MDL lead counsel. Many lead counsels are just end of the libne lawyers and are not taking cases, others are. Your attorney must be familiar with the MDL process. for the Vaginal mesh Helpline dial 1 877 522-2123

]]>Vaginal Mesh Helpline, Vaginal Mesh Lawyers, Beware of Email Blastshttp://vaginalmeshhelpline.com/vaginal-mesh-helpline-vaginal-mesh-lawyers-beware-of-email-blasts Wed, 04 Jul 2012 16:00:57 +0000http://vaginalmeshhelpline.com/?p=1665Are you suffering from a vaginal mesh implant? Beware of email blasts and email solicitations. Be aware that these may or may not be coming from lawyers. Leads companies collect these and sell them to lawyers for $400-$800 a lady with a mesh. Yes my dear mesh victims they are after you and they really […]

]]>Are you suffering from a vaginal mesh implant? Beware of email blasts and email solicitations. Be aware that these may or may not be coming from lawyers. Leads companies collect these and sell them to lawyers for $400-$800 a lady with a mesh. Yes my dear mesh victims they are after you and they really do not care about how you are suffering. They are being sent to everyone. These people do not know you have a mesh. Men are even getting them. These may just be money machines after you and trying to cash in on your misery. You may have gotten email blasts. These may be leads companies, not a lawyers. If you are suffering from a vaginal mesh and want some good solid concerned medical advice and legal help call the Vaginal Mesh Helpline and speak to a female medical social worker, MSW, LCSW, with almost 3 decades experience working with people in need and over two decades working with the legal community. All our lawyers are end of the line attorneys.All lawyers we deal with go thru an extensive screening process. All the lawyers in our network work with each other to your best interest. They are end of the line lawyers. Each office has a female representative or lawyer experienced with the mesh. Beware all the emails and direct solicitations. These are not allowed in many states.

We care about you and our goal is to get you to a doctor that can help you and get you justice for your misery. You are not alone. Be aware that the statute of limitations is running very close in many states. You should have legal representation but, chose wisely. For help call us at 1 877 522-2123

]]>J & J Sold Vaginal Mesh Implant After Sales Halt Order, Vaginal Mesh Lawyers Reporthttp://vaginalmeshhelpline.com/j-j-sold-vaginal-mesh-implant-after-sales-halt-order-vaginal-mesh-lawyers-report Tue, 26 Jun 2012 14:39:07 +0000http://vaginalmeshhelpline.com/?p=1661It appears J & J sold the vaginal mesh to unsuspecting doctors and victims even after they were ordered tp stop. So many women call us daily with so much pain and agony. These poor women were victims of a manudfacturer whi apparently put profits over people. There is nothing a fine or slap on […]

]]>It appears J & J sold the vaginal mesh to unsuspecting doctors and victims even after they were ordered tp stop. So many women call us daily with so much pain and agony. These poor women were victims of a manudfacturer whi apparently put profits over people. There is nothing a fine or slap on the wrist can do to bring a womend life back to normal. We are reaching out to you. If you have not added your name to the vaginal mesh lawsuits you must now. We must obtain justice. See article below

J&J Sold Vaginal Mesh Implant After Sales Halt Ordered By David Voreacos and Alex Nussbaum on June 26, 2012

Johnson & Johnson (JNJ) (JNJ), the biggest health-care products maker, continued to sell a vaginal mesh implant for nine months after U.S. regulators told the company to stop marketing the device, according to court records. The U.S. Food and Drug Administration told J&J in a letter on Aug. 24, 2007, to halt Gynecare Prolift sales until the agency decided whether the device was “substantially equivalent” to other products on the market. The FDA cited the “potential high risk for organ perforation” when surgeons insert the mesh vaginally to support weakened pelvic tissue. “You may not market this device until you have provided adequate information” on 16 potential deficiencies and received FDA approval, the agency told New Brunswick, New Jersey-based J&J in the letter. “If you market the device without conforming to these requirements, you will be in violation of the Federal Food, Drug and Cosmetic Act.” The FDA cleared the device in May 2008 without ordering sanctions, after nine months of negotiations with J&J’s Ethicon unit. The company faces more than 1,400 lawsuits by women who say the mesh caused organ perforation, pain, scarring and nerve damage. Lawyers for the women say the device’s approval history could increase J&J’s cost to resolve the litigation. “If a company knows the FDA tells them, ‘Don’t sell a device,’ they’re supposed to not sell it,” Adam Slater, an attorney suing on behalf of 150 women, said in a phone interview. “It’s egregious that J&J was selling the device without clearance.” Letter Unsealed The 2007 letter was part of a group of documents filed under seal in state court in Atlantic City, New Jersey, and made public in May at the request of Slater, a partner at Mazie Slater Katz & Freeman LLC in Roseland, New Jersey. Lawsuits also are pending in federal court in Charleston, West Virginia. J&J began selling (JNJ) the Prolift in 2005 without filing a new application after determining on its own that it was substantially similar to the Gynemesh, a company device already approved by the FDA, said Matthew Johnson, a J&J spokesman, in an e-mail. The device maker relied on FDA guidance for when companies must submit new applications, Johnson said. The FDA disagreed with J&J’s interpretation and required a new application that prompted questions in the August 2007 letter, Morgan Liscinsky, an agency spokeswoman, said in an e-mail. J&J faced no sanctions because the FDA determined that the company applied the guidance in good faith and it “promptly complied” when the agency required a new application, Liscinsky said. Fines, Injunctions Sanctions for selling products without approval may include fines, injunctions against a company or senior managers and the seizure of illegally marketed devices, Liscinsky said. The August 2007 letter was “only one part of an extended dialogue with FDA in 2007-08, and it is out of context,” Johnson said in the e-mail. “Throughout this process, our actions were responsible, appropriate and consistent with FDA regulations.” Henry G. Garrard III, a lawyer who represents women suing in federal court in Charleston, said the FDA’s failure to take additional steps to halt Prolift sales or to sanction J&J raises questions about the agency’s power to protect patients. “Companies know the FDA has little enforcement ability and scarce resources,” Garrard, of Blasingame, Burch, Garrard & Ashley PC in Athens, Georgia, said in a phone interview. “Every woman in America who has been implanted with these devices absolutely should be outraged,” he said. “They should be mad at the company because the company knew they could get away with it.” Ordered Study Surgeons thread mesh implants through vaginal incisions and use the devices to treat incontinence or pelvic organ prolapse, a condition in which weakened muscles fail to support organs. Almost 300,000 were used in U.S. women in 2010, the FDA estimated last year. An FDA database of reported malfunctions, deaths and serious injuries shows the agency received 123 complaints about the Prolift from 2005 to May 15, 2008, when the device won clearance. The company said in a September 2007 letter to regulators that reported problems accounted for less than 0.5 percent of sales for both Gynemesh and Prolift. An agency report in July found a fivefold jump in deaths, injuries or malfunctions tied to prolapse mesh inserted vaginally. In January, the FDA ordered J&J, Murray Hill, New Jersey-based C.R. Bard Inc. (BCR) (BCR) and other manufacturers to study organ damage and complications related to the products.

J & J has just removed the Gynacare of the market for four of the devices and changed the labeling for a fifth. They claim this not to be a recall and for financial reasons only. The vaginal mesh helpline can only say “how very interesting indeed”.

]]>New Study Regarding Vaginal Slings, Vaginal Mesh Updatehttp://vaginalmeshhelpline.com/new-study-regarding-vaginal-slings-vaginal-mesh-update Tue, 26 Jun 2012 03:27:49 +0000http://vaginalmeshhelpline.com/?p=1644There appears to be a new study that actually speaks positively about the vaginal sling. This study concludes that vaginal mesh slings reduce the risk of post-surgical incontinence. However we know at the Vaginal Mesh Helpline that the by the real life complications our suffering women callers are experiencing that the benefits do not appear […]

]]>There appears to be a new study that actually speaks positively about the vaginal sling. This study concludes that vaginal mesh slings reduce the risk of post-surgical incontinence. However we know at the Vaginal Mesh Helpline that the by the real life complications our suffering women callers are experiencing that the benefits do not appear to out weigh the “pain and suffering”. According to research published in the New England Journal of Medicine on June 21, 2012 , women who undergo surgery with a vaginal mesh sling to treat post-operative stress urinary incontinence are less likely to experience incontinence a year later, but more likely to suffer a transvaginal mesh injury like an infection, urinary leakage, and major bleeding. How nice of them to see both sides of the story here.

University of Michigan researchers compared women who went through POP surgery and were implanted with a transvaginal mesh sling with those who went through the same surgery but were not implanted with the sling. The sling used in this study was the Gynecare TVT, made by Ethicon, a subsidiary of Johnson & Johnson. The device is made of surgical mesh and is designed to lift the bladder and relieve pressure to prevent incontinence. The Gynacare mesh has been pulled off the market for four of the mesh implants under the Gynacare name and the fifth has a new stronger label warning for implantation thru the abdomin only. This is hardly a positive for the Gynacare Mesh. We all know that a manufacturer, whose stock is doing well, does not just pull a money maker off the market. Obviously the negative, as in lawsuits, outweighs the positive.

However according to the results of this study, the transvaginal mesh sling cut in half a woman’s risk of subsequently developing incontinence. After three months, 23.6 percent of the women with the sling and 49.4 percent of those without it had urinary incontinence. Twelve months after surgery, 27.3 percent of the sling group and 43 percent of the non-sling group had urinary incontinence.

On the other hand, nearly 7 percent of those with the sling suffered bladder perforation, compared to 0 percent in the non-sling group, and 31 percent of those with slings experienced urinary tract infections, compared to 18.3 percent of those without slings. Finally, those with the sling also experienced bleeding complications (3.1 percent versus 0 percent), and incomplete bladder emptying six weeks after surgery (3.7 percent versus 0 percent).

Very interesting as we note the announcement by Johnson & Johnson that they are discontinuing the Gynecare TVT Secure vaginal mesh. At the Vaginal Mesh Helpline we listen to women daily. They tell us their stories of serious, painful complications like infections, erosion, pelvic pain, urinary problems, bleeding , painful sexual intercourse and suurgery after surgery to get the mesh removed.

Cheryl Iglesia, M.D., of the Georgetown University, has noted in a commentary that the vaginal slings are different from transvaginal mesh, which is often used to create broader support of pelvic organs. Slings are smaller and shaped like straps, about 1 cm wide and 10 cm wide, while transvaginal mesh sheets can span up to 10 cm wide and 20 cm long.

The study further noted that though beneficial, vaginal slings are not without risk. The vaginal mesh helpline is trying to locate doctors who can help women with the removal of the mesh and are advised to discuss the other options with their doctors, and reconsider putting another mesh on top of the already failing one.

The Vaginal Mesh Helpline encourages women to step forward and pursue being a part of the current MDL litigations. A message must be sent to the manufacturers. We can help you locate a vaginal mesh doctor and first line vaginal mesh lawyer who will not refer your case to another lawyer because he is inexperienced in mass tort litigation. The vaginal mesh helpline does have very strict criteria and an interview process for any attorneys who wish to be involved with the helpline.

Vaginal mesh helpline reports that medical device manufacturer Johnson & Johnson announced a product label change to restrict the use of the Gynemesh vaginal mesh on June 4, 2012.* In a letter to the Court in the pending vaginal mesh MDLs, the company wrote: “Ethicon also plans to update the product labeling for Gynecare Gynemesh PS…to restrict the indication for use to the abdominal sacrocolpopexy procedure for the treatment of pelvic organ prolapse.” In other words, the product would no longer be indicated for use in transvaginal surgeries and would only be inserted through an incision at the bottom of the abdomen.

J&J also informed the Court that they would cease “commercializing” four of its Gynecare vaginal mesh systems. According to The New York Time, the company maintained that the end of sales was not based on safety concerns: “but was based on the products’ commercial viability ‘in light of changing market dynamics, and is not related to safety or efficacy.’”*** However other reports state J & J has opted to remove the mesh form the market due to concerns of injury.

Ethicon is changing the label so that the product is only implanted through the abdomen rather than the vagina . This is interesting a the vaginal implanted mesh have caused the most injury. There appears to be differing views in the different news reports.

We would hope all mesh products would be pulled but, this is a good first step. It does not,however, bring justice to the women who have suffered and had their lives destroyed by these mesh products. If you have a mesh, have had your mesh removed, adjusted or have mesh complications you must file a mesh lawsuit. The statute of limitations for many states is running close. We want to hear specifically from women who have been rejected by a vaginal mesh law firm for their mesh lawsuit. We may be able to help you. Do not give up.